This week, a US Appeals Court has ruled at Allergan and St. Regis Mohawk Indian Tribe can’t use tribal sovereign immunity to shield patents on the dry-eye drug Restasis from challenges at the U.S. Patent and Trademark Office. The decision comes after the controversial move by Allergan in September 2017 to pay the Saint Regis Mohawk Tribe of Upstate New York $15 million a year to take ownership of the company’s Restasis patents

Allergan thought they were being clever, as the Saint Regis Mohawk Tribe of Upstate New York are a sovereign entity and thus claimed immunity from civil patent challenges. However, Mylan NVTeva Pharmaceutical Industries Ltd., and Akorn Inc all filed challenges against Allergan and this week the immunity has been overturned.

Reviews of the challenges filed against Allergan will now proceed at the Patent Trial and Appeal Board in Alexandria, Virginia. To shield Restasis from generic competition before the patents’ 2024 expiration date, the company will need to win in both venues.

Restastis is the company’s second-best selling drug, second only to the company’s wrinkle treatment, Botox. Sales from the dry-eye drug make up more than 9 percent of the company’s total revenue, generating $1.5 billion in sales last year. That number, though, is anticipated to drop significantly if low-cost versions enter the market.


Image source: Casimiro PT

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